[Remote] Director, Bioanalytical and Translational Science at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

The ideal candidate will be an experienced and independently motivated scientist with expertise in bioanalytical strategy, operations, and vendor management. Demonstrated technical abilities with a flexible approach and strong ability to roll-up-your sleeves to get the job done under tight timelines and changing scope are essential. Experience with CAPA is preferred.

Responsibilities

This role involves leading the design, development, and implementation of bioanalytical assays to support preclinical and clinical pipeline advancement. Responsibilities include contributing to multiple drug programs, serving as a bioanalytical subject matter expert, contributing to study designs, presenting data and workplans in cross-functional meetings, collaborating with toxicologists and clinical pharmacologists, and managing external bioanalytical vendor relationships. The position also entails overseeing outsourced methods, ensuring compliance with FDA and ICH guidelines, driving PK, PD, and immunogenicity testing strategy, participating in regulatory and clinical document authoring, resolving bioanalytical method issues, managing critical reagent life-cycle, and preparing data for cross-functional presentations.

Skills

Bioanalytical Strategy

Vendor Management

LC-MS

ELISA

qPCR

Immunogenicity Assays

Cell-based Biomarker Assays

In vitro Biomarker Assays

Preclinical Studies

Clinical Studies

Drug Development

Biomarker Method Development

Cross-functional Collaboration

Nonclinical Toxicology

Clinical Pharmacology

Amylyx Pharmaceuticals

Develops treatments for neurodegenerative diseases

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, focusing on conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's Disease (ALZ). Their main product, AMX0035, is currently undergoing clinical trials to assess its effectiveness. The CENTAUR ALS trial showed promising results for ALS patients, using a randomized, double-blind, placebo-controlled design to ensure reliable outcomes. They are also conducting the PEGASUS trial to evaluate AMX0035's safety and effectiveness in Alzheimer's patients. Unlike many competitors, Amylyx emphasizes community engagement and awareness campaigns, such as ALS Awareness Month, to educate the public and foster support for those affected by these diseases. The company's goal is to bring effective therapies to market that improve patient outcomes and enhance the quality of life for individuals suffering from neurodegenerative conditions.

Cambridge, MassachusettsHeadquarters

2013Year Founded

$166.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees